Effect of Acupuncture on Human Brain Activity - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 24, 2008

Start Date ^ICMJE

May 2005

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Brain activity during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Brain activity; measured via fMRI throughout the study

Change History

Complete list of historical versions of study NCT00200889 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Acupuncture on Human Brain Activity

Official Title ^ICMJE

Exploring Neurocircuitry of Acupuncture Action With fMRI

Brief Summary

This study will determine how acupuncture affects human brain activity.

Detailed Description

Acupuncture is an ancient Chinese practice involving the insertion of needles into specific parts of the body for therapeutic purposes. Although the practice has become more popular in the West, the underlying mechanisms of acupuncture have not been thoroughly examined. This study will determine how acupuncture affects human brain activity, particularly during deqi, a unique sensation experienced during acupuncture that is considered essential to the clinical effectiveness of the practice.

This study will comprise 2 clinic visits. At Visit 1, participants will be randomly assigned to receive manual acupuncture; electro-acupuncture, which passes an electrical current through the needles; or some type of sensory stimulation. At Visit 2, participants will again be randomly assigned to receive one of the three interventions. As participants receive their assigned intervention, they will undergo functional magnetic resonance imaging (fMRI) brain scans. Participants will also have their heart rate monitored during the brain scans.

Study Phase

Phase 0

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Procedure: Manual acupuncture
Procedure: Electro-acupuncture
Procedure: Sensory stimulation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Right-handed

Exclusion Criteria:

Any condition contraindicating an fMRI brain scan
Any neurological or psychiatric disorders
Any pain syndromes

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Lauren LaCount

llacount@nmr.mgh.harvard.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00200889

Responsible Party

Vitaly Napadow, Ph.D., Massachusetts General Hospital Dept. of Radiology

Study ID Numbers ^ICMJE

K01 AT002166-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Vitaly Napadow, PhD

Harvard University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP